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Effect of Nutrition Labeling on Fast Food Choices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127660
First Posted: August 8, 2005
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: December 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition: Healthy
Interventions: Behavioral: Menu: calories=yes, value pricing=no
Behavioral: Menu: calories=yes, value pricing = yes
Behavioral: Menu: calories=no, value pricing = no

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Menu: Calories=Yes, Value Pricing=no Calories listed on menu, but value pricing was not in place.
Menu: Calories=Yes, Value Pricing = Yes Calories listed on menu, value pricing in place.
Menu: Calories=no, Value Pricing = no Calories not listed on menu, value pricing not in place
Menu: Calories=no, Value Pricing = Yes CONTROL CONDITION: calories not listed on menu, value pricing in place.

Participant Flow:   Overall Study
    Menu: Calories=Yes, Value Pricing=no   Menu: Calories=Yes, Value Pricing = Yes   Menu: Calories=no, Value Pricing = no   Menu: Calories=no, Value Pricing = Yes
STARTED   153   154   148   150 
COMPLETED   150   151   143   150 
NOT COMPLETED   3   3   5   0 
Protocol Violation                3                3                5                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Menu: Calories=Yes, Value Pricing=no Calories listed on menu, but value pricing was not in place.
Menu: Calories=Yes, Value Pricing = Yes Calories listed on menu, value pricing in place.
Menu: Calories=no, Value Pricing = no Calories not listed on menu, value pricing not in place
Menu: Calories=no, Value Pricing = Yes CONTROL CONDITION: calories not listed on menu, value pricing in place.
Total Total of all reporting groups

Baseline Measures
   Menu: Calories=Yes, Value Pricing=no   Menu: Calories=Yes, Value Pricing = Yes   Menu: Calories=no, Value Pricing = no   Menu: Calories=no, Value Pricing = Yes   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   151   143   150   594 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      32  21.3%      30  19.9%      45  31.5%      40  26.7%      147  24.7% 
Between 18 and 65 years      95  63.3%      92  60.9%      80  55.9%      96  64.0%      363  61.1% 
>=65 years      23  15.3%      29  19.2%      18  12.6%      14   9.3%      84  14.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      81  54.0%      94  62.3%      89  62.2%      89  59.3%      353  59.4% 
Male      69  46.0%      57  37.7%      54  37.8%      61  40.7%      241  40.6% 
Region of Enrollment 
[Units: Participants]
         
United States   150   151   143   150   594 


  Outcome Measures

1.  Primary:   Energy Intake   [ Time Frame: After meal ]

2.  Primary:   Total Calories of Meal Ordered   [ Time Frame: single study visit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Meal choices were tested on just one occasion.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Harnack, DrPH
Organization: University of Minnesota
phone: 612-626-9398
e-mail: harna001@umn.edu


Publications of Results:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00127660     History of Changes
Other Study ID Numbers: DK67599 (completed)
R01DK067599 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2005
First Posted: August 8, 2005
Results First Submitted: December 1, 2014
Results First Posted: August 28, 2017
Last Update Posted: September 1, 2017